China’s overhaul of medical device and IVD regulations could mean huge benefits. Manufacturers have additional options for fast-track approvals and more flexible testing / clinical-evaluation pathway requirements. Is your company positioned to benefit from faster and less-costly market entry?
Medical devices and IVD manufacturers are facing a vastly different regulatory landscape in China. This all-in-one resource provides an overview on many new regulations, along with clear explanation of how these could affect your registrations, renewals and post-market compliance.
Get your copy of the 2021 Blue Book today with the completion of a survey:
This 60+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Quality Management System, COVID-19, CDx and specific products for attention:
“The China NMPA Blue Book will help foreign medical device and diagnostic companies to overcome the barriers and to be kept informed of the Chinese regulatory system due to language and culture differences. It will be a valuable tool for overseas companies to enter China.”
— Mr Gong Zhi Jun, Director Administration Institute of Executive Development NMPA